Recruiting

Acoustic & Electrical Stimulation

Sponsor:

UCLA

Code:

NCT03511807

Conditions

Tinnitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Electrical

Acoustic

Study Details

Brief summary:

Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus.

It has been found that electrical stimulation of the inner ear can reduce and in some cases eliminate tinnitus. The purpose of this research is to investigate both acoustic and electrical stimulation of the inner ear as a possible treatment of tinnitus.

In both acoustic and electrical testing conditions, the subjects will be instructed to be familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be presented through headphones in a noiseless environment, and the subject will be asked to report on the loudness of the presented sound and the level of the tinnitus at 20-second intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual inhibition.

Electrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various electrical signals will be used to evaluate the reduction in the tinnitus perception by the subject. The subjects will rate the loudness of the tinnitus before, during, and after the electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of life of the subjects. Hearing tests will be used before and after the procedures. The long term goal of this research is to develop a device to treat tinnitus in people who can hear and to develop programs for cochlear implants that help treat tinnitus in deaf people.

Conditions

Tinnitus

Study ID

NCT03511807

Start date

Jan 1, 2017

Status verified date

Jun, 2026

Completion date

Nov, 2032

Anticipated

Primary completion date

Nov, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 18 years or older
2. Male or female
3. Tinnitus present for 6 months or more
4. Adequate command of English to reliably describe the unusual sensory percepts provided by electrical stimulation, and to complete surveys.
5. For patients undergoing electrical stimulation via a cochlear implant, they should have a cochlear implant prior to enrollment (not applicable for acoustic stimulation)

Exclusion Criteria:

1. Aged less than 18 years
2. Active illicit drug use, alcohol dependence
3. Treatable cause of tinnitus
4. History of psychosis
5. Abnormalities of the ear canal or ear drum
6. Chronic middle ear disease
7. Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.
8. Pregnant or breastfeeding.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Electrical/ Acoustic stimulation

Interventions

Electrical

For the electrical stimulation:

An electrode will be inserted into the ear canal which will be stimulated.

Acoustic

For the acoustic stimulation:

A typical sound will be presented for 6 minutes. Loudness is reported for 4 minutes after the stimulus offset to measure the presence and duration of the residual inhibition. If a successful acoustic stimulus is found, the subject will be given a series of sound files to listen to on a digital music player (CD or MP3 player) and will be asked to listen to each sound file (5 minute duration) and record their tinnitus loudness/annoyance during and after each sound stimulation. For some subjects, the investigators will use music on a digital music player (MP3 player) to see if music listening and music exercises will help reduce the intensity or annoyance level of the tinnitus (using the same surveys). These music-based exercises will involve training in recognition of musical intervals (e.g., octaves, fifths, and thirds).

Primary outcome measure

  • Audiogram [ Time Frame: Occurs once at the beginning of subject participation (less than one hour) ]
  • Otoacoustic Emissions (OAE) [ Time Frame: Occurs once at the beginning of subject participation (less than one hour) ]
  • Tinnitus Handicap Inventory (THI) [ Time Frame: Outcome will be measured during each participant visit through study completion which can be an average of 1 year ]
  • Medical Outcomes Study Questionnaire Short Form 36 (SF-36) Health Survey Quality of life metrics. [ Time Frame: Outcome will be measured during each participant visit through study completion which can be an average of 1 year ]

Central Contacts and Locations

Central contacts

Hamid Djalilian, MD

tinnitus@uci.edu

William Pu, MS

entclinicalstu@hs.uci.edu

Locations

Hamid R. Djalilian

Recruiting

Irvine, California, United States, 92612

Contacts

William Pu, MS

entclinicalstu@hs.uci.edu

Amanda Francis, BA

entclinicalstu@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-06-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.